Clinical Study of the Effects of Compound Kushen Injection on Radiation-induced Oral Mucositis in Head and Neck Cancer Patients.
试验速览
- 阶段
- 4 期
- 入组人数
- 144
- 试验地点
- 12
- 主要终点
- Clinical grade of radioactive oral mucositis
研究概览
简要总结
Oral mucositis (OM) is an acute side effect of radiotherapy for head and neck cancer (HNC). OM associated pain affects oral functions and nutrition of the patient that may result in discontinuity of treatment.The purpose of this clinical study is to evaluate the therapeutic effects of Compound Kushen Injection (CKI) on oral mucositis caused by radiotherapy of head and neck cancer.
详细描述
Patients with oral mucositis caused by radiotherapy for Head and Neck Cancer，will be enrolled in the trial, then seprated randomly in two group,the experimental group treated with Levofloxacin injection plus CKI; the contral group treated with Levofloxacin injection only. Clinical grade of radioactive oral mucositis，Oral pain score，Completion and duration of interruption of radiotherapy， Completion of chemotherapy during concurrent chemoradiotherapy，weight change，Food intake (liquid food, semi liquid food)，recovery time of oral mucositis will be compared before treatment, 3 days, 5 days and 7 days after treatment between the experimental group and the control group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients are pathologically diagnosed as stage III or stage Ⅳ squamous cell carcinoma of head and neck cancer (including nasopharyngeal carcinoma)and are in accordance with the diagnostic criteria of radiotherapy induced mucositis/ stomatitis;
- •Patients have no prior history of radiotherapy, and grade III oropharyngeal mucositis occured after the first radiotherapy;
- •Patients have no stomatological diseases such as ulcer, edema and exudation in the oropharyngeal mucosa before radiotherapy;
- •Eastern Cooperative Oncology Group (ECOG) performance Score is 0 or 1;
- •The function of each organ is basically normal, including: hemoglobins ≥ 9g/dL, platelets ≥ 80×10^9/L, leukocytes ≥ 3×10^9/L, liver function within 3 times the upper normal limit, creatinine clearance ≥ 60mL/min;
- •Patients aged between 18 and 75 years;
- •Patients have a life expectancy of at least 6 months;
- •Patients have fully understood the study and signed the informed consent voluntarily prior to any related procedures of the study.
排除标准
- •Patients who have received CoKS or systemic antibiotic treatment within 2 weeks before treatment;
- •Patients who have a history of head or neck surgery (except biopsy);
- •Female patients who are pregnant or breast feeding or female of pregnancy potential with a positive pregnancy test before treatment;
- •Patients with serious or uncontrolled organic diseases or infections, such as decompensate cardiac function failure, pulmonary function failure, liver function failure, renal function failure, causing unability to tolerate radiotherapy;
- •Patients who have radiotherapy contraindications;
- •Patients who are allergic to the study medications or quinolones;
- •Patients have serious psychological or psychiatric disorders, drug abuse or alcohol dependence in the past;
- •Patients are currently participating in another clinical study or have participated in another clinical trial in the past 30 days;
- •The investigator believes that it is not appropriate to participate in this trial.
研究组 & 干预措施
test group
- CKI was injected intravenously for 7 days, once a day, 20ml each time；
- Levofloxacin injection were injected intravenously for 7 days, once a day, 0.5g each time,
干预措施: Levofloxacin Injection (Drug)
test group
- CKI was injected intravenously for 7 days, once a day, 20ml each time；
- Levofloxacin injection were injected intravenously for 7 days, once a day, 0.5g each time,
干预措施: Compound Kushen Injection（CKI） (Drug)
control group
Levofloxacin injection were injected intravenously for 7 days, once a day, 0.5g each time.
干预措施: Levofloxacin Injection (Drug)
结局指标
主要结局
Clinical grade of radioactive oral mucositis
时间窗: From baseline to day 7.
Treatment efficacy measured by Chinese guideline "Clinical diagnosis and treatment guidelines for tumor" Significant: no leukoplakia or ulcer of the oral mucosa, mild hyperemia(grade Ⅰ), able to eat regular diet. Effective: moderate hyperemia of the oral mucosa, mild leukoplakia or patchy ulcerations(grade Ⅱ)，semi fluid intake, but not interfering with radiotherapy. Ineffective: severe hyperemia of the oral mucosa, flaked leukoplakia or ulcer (grade III or above), fluid intake，severe symptoms interfering with radiation therapy , intravascular nutrition or antibiotic treatment. Total effective rate = (significant + effective) / total cases × 100%.
次要结局
- Oral pain score(From baseline to day 7.)
- Completion of radiotherapy during concurrent radiotherapy(From baseline to day 7.)
- Duration of interruption of radiotherapy(From baseline to day 7.)
- Completion of chemotherapy during concurrent chemoradiotherapy(From baseline to day 7.)
- Weight change(From baseline to day 7.)
- Food intake (liquid food, semi liquid food)(From baseline to day 7.)
- Recovery time of oral mucositis(From baseline to day 7.)